MAUDE Adverse Event Report: SPROTTE NRFIT; SPINAL NEEDLE

Model Number 051163-29A

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).As soon as further information becomes available a follow up report will be sent in to the agency.

Event Description

Irn# (b)(4).Nrfit packet contained a non nrfit spinal needle.Anaesthetist was unable to administer block without removing and changing the spinal needle.Narrative from the cer: the hospital have converted to nrfit.They use nrfit sprotte.They opened a box of nrfit sprotte needles in theatres, opened the packet, took the needle out, inserted it into the patient, and found the nrfit syringe wouldnt connect.On closer inspection, they found this needle to be a luer sprotte.Staff then opened another box and found 1 x more unit of a luer sprotte, in a nrfit sprotte box.Hence the 2 x lot numbers.Theatre staff on site disposed of the needles into the sharps bin.

Event Description

Irn# (b)(4).Nrfit packet contained a non nrfit spinal needle.Anaesthetist was unable to administer block without removing and changing the spinal needle.Narrative from the cer: the hospital have converted to nrfit.They use nrfit sprotte.They opened a box of nrfit sprotte needlesin theatres, opened the packet, took the needle out, inserted it into the patient, and found the nrfit syringe wouldnt connect.On closer inspection, they found this needle to be a luer sprotte.Staff then opened another box and found 1 x more unit of a luer sprotte, in a nrfit sprotte box.Hence the 2 x lot numbers.Theatre staff on site disposed of the needles into the sharps bin.

Manufacturer Narrative

Event took place in the uk.As soon as further information becomes available a follow up report will be sent in to the agency.Based on risk assessment and clinical assessment this file is considered as closed.

• Brand Name: SPROTTE NRFIT
• Type of Device: SPINAL NEEDLE
• MDR Report Key: 11234658
• MDR Text Key: 258932162
• Report Number: 9611612-2021-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223026981
• UDI-Public: 14048223026981
• Combination Product (y/n): N
• PMA/PMN Number: K160294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 051163-29A
• Device Catalogue Number: 051163-29A
• Device Lot Number: 1343
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention